Remarkable advances in genomics technologies bring the promise of extraordinary changes in healthcare — and some of those changes are arriving now. What’s unfolding are nine trends that we think will shape the life science markets in this accelerating genomics revolution. First, some background on how we got here.
In any industry, there are the experts who become known as the foremost voices of the industry. Biosimilar evangelist, Bert Liang, CEO of Pfenex and chair of the Biosimilars Council describes how far the U.S. biosimilar industry has progressed, as well as how far it has yet to go, offering biosimilar makers some important goals to strive for.
Whether you are a life science startup with a brick-and-mortar office or working as a virtual company, at some point the question comes up: Do we need a quality system? Or perhaps your question is, What is a quality system?
While Express Scripts' Jonah Houts thought working on federal law, specifically the Biologics Price Competition and Innovation Act (BPCIA), was the hardest task he’d face in his career, he encountered a whole new level of difficulty when addressing state government affairs to promote biosimilar use.
FDA and the EU have taken serious enforcement actions against firms in the other’s geographic jurisdiction during the calendar year 2016. In the preceding article, we looked at European inspectorate actions against sites in the U.S. Issues identified as problematic included deficiencies in aseptic processing of parenteral drugs, data integrity concerns, lack of controls to prevent cross-contamination, and failure to adequately address observations from previous inspections. FDA had inspected each of the three facilities within the past year.
In my previous article, I broadly introduced the Six Sigma approach to process excellence, along with some examples of its application and a discussion of its Sigma levels, roadmap, and educational and experience levels (belt colors). If you haven’t read that article, it would be helpful to do so before proceeding with this installment, which will begin a deeper dive into the Six Sigma process — also known as DMAIC, which stands for define, measure, analyze, improve, and control.
Throughout an expansive presentation about the biosimilar market’s progression, Sanford Bernstein analyst Ronny Gal homed in on four topics I think are important to reiterate.
In the coming years, prudent policymaking will be necessary to expand biosimilar volumes and provide patients with greater access to these life-saving drugs.
A study recently published in the BJCP go a long way toward providing a clear example of what regulatory flexibility looks like in the EMA. But where does the FDA, which got a late start with biosimilars, stand in terms of regulatory flexibility today?
Combination product development is a complex matter governed by different areas of regulatory oversight. In my previous article, we discussed which current good manufacturing practice (cGMP) requirements apply when drugs, devices, and biological products are combined, and the typical pitfalls to avoid when doing so.
The unique targeting capabilities and promising clinical trial results of antibody-drug conjugates (ADCs) have made them an exciting and promising treatment in the fight against cancer. According to recent analysis, experts anticipate the ADC market to be worth $10 billion annually by 2025. However, despite this tremendous growth, drugmakers still face a number of challenges in the manufacturing process for ADCs. Below are five key areas where pharmaceutical manufacturers may face the biggest uphill battles.
Compared to traditional antibody expression, where routine purification and analytical strategies have been established over the last few years, next-generation biologics have complex designs. If you are first in class or you have a very bespoke up- and downstream process, it also means you will have bigger hurdles to overcome when it comes to regulatory support and filing. At Lonza, these challenges are addressed with the GS™ expression platform.
No single strain or vector is capable of being the best expression option for all types of biopharmaceuticals. Experts from Lonza answers questions about the proprietary expression platforms the company has assembled to rapidly generate high-producing cell lines for biological candidates.
Proving therapeutic equivalence is an important step in the approval process for a biosimilar. The research needed is time, labor and resource intensive, making it critical to maximize the investment. UBC’s Clinical Development team is supporting a sponsor with a Phase IV study of a gastroenterology biosimilar. This late phase study has yielded three important lessons for biosimilar manufacturers.
The pharmaceutical industry is moving faster than ever before, continually evolving to meet the changing and growing needs of patients around the world. The industry must continue to adapt in order to meet the increasing demands for new medicines.
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